Job Description
Sr. Medical Director, Drug Safety & Pharmacovigilance
Join to apply for the Sr. Medical Director, Drug Safety & Pharmacovigilance role at Xencor
Sr. Medical Director, Drug Safety & Pharmacovigilance
Join to apply for the Sr. Medical Director, Drug Safety & Pharmacovigilance role at Xencor
Sr. Medical Director, Drug Safety & Pharmacovigilance Introduction: Xencor is a public, clinical-stage biopharmaceutical company located in the Los Angeles area (Pasadena) and in San Diego. Our focus is developing high-potential XmAb bispecific T-cell engagers and additional engineered drug candidates that leverage our differentiated technology platforms, and we are advancing our pipeline toward clinical proof-of-concept decisions. Our goal is to create high-impact therapeutics for patients with cancer and other serious diseases. More than 20 XmAb drug candidates engineered with our technology are in clinical development, and three XmAb medicines have been marketed by partners. For more information, please visit We have an excellent opportunity for a
Sr. Medical Director, Drug Safety & Pharmacovigilance , to join our team.
This position can be fully remote or based out of our San Diego office. This position requires travel to the San Diego office including up to quarterly visits. Summary: Responsible for managing drug safety and PV related activities involving Xencor products.
Primary Responsibilities: - Performs signal detection activities to ensure signal identification and evaluation, including individual and aggregate data analyses, interpretation of safety signals and trends, and documentation and communication of safety assessments for all investigational products in compliance with global pharmacovigilance and regulatory requirements.
- Provides medical and strategic input for adverse event monitoring, coding, and signal detection to ensure that global PV regulatory requirements for case reporting and management are met.
- Performs medical review of individual case safety reports (ICSRs), including confirmation of triage and assessments, review of narratives, ensures accurate coding and composes Company Comments. Contributes to the creation of analysis of similar events
- Works collaboratively within the Drug Safety and Pharmacovigilance department, across departments, and with partner companies to achieve PV and company goals.
- Focuses on tactical execution while providing direction on process improvements and contributing to the strategic buildout of the department
- Participates in safety activities for Xencor investigational products, including development and implementation of relevant policies and procedures
- Collaborates with partners on safety monitoring and signal detection and risk management activities.
- When relevant, participates in establishing and maintaining Safety Data Exchange Agreements
- Collaborates, reviews and contributes to relevant sections of clinical and regulatory documents, including protocols, informed consent forms, study reports, integrated summaries of safety, expedited safety reports, DSURs, marketing applications and other regulatory submission documents on assigned projects
- Provides direction and monitors contracted vendors in the collection, coding, processing and reconciliation activities involving safety information in clinical trial settings and, when relevant, in the post marketing setting.
- Leads the development and finalization of periodic safety data reports to meet reporting obligations (e.g., DSURs/ IND Annual Reports and/or PADERs/ PSURs/PBRERs)
- Supports the development, review and maintenance of appropriate safety sections of key product documents including: IBs (including RSI determination), study protocols, ICFs, CSRs, CCDS.
- Constructs and summarizes scientific literature relevant to Drug Safety on assigned projects, which includes literature reviews for safety signals
- Participates in inspection readiness activities and preparation as needed
- Stays current with international pharmacovigilance requirements and guidelines (focus on FDA and EMA)
- Functions as a safety subject matter expert (SME) for cross-functional departments (e.g., Regulatory, Quality Assurance, Clinical) and vendors to ensure appropriate and timely handling of safety information/issues.
- Safety support provided with knowledge of new and updated regulations/ guidelines which impact Drug Safety & Pharmacovigilance.
- Participates as a SME during internal audits and assist the Drug Safety/PV team during Agency inspection activities, as required.
- Adheres to all department and company-wide policies regarding conduct, performance and procedures
- Provides oversight and direction to direct and indirect reports, as applicable, in accordance with the organization’s policies and procedures. The responsibilities may include, but are not limited to recruiting, training, communicating job expectations, appraising and managing job performance, delivering feedback and coaching, and providing career development planning and opportunities
- Provides strategic leadership and direction to the pharmacovigilance team, ensuring the effective and compliant operation of safety systems.
- Ensures that the above tasks are performed in the most efficient manner possible, commensurate with quality, accuracy, and timeliness and in accordance with current global regulatory requirements
- Collaborates with cross-functional teams and communicate safety findings and recommendations to senior management.
- Performs other duties as required.
Education/Experience/Skills: Position requires an Medical Doctor (MD) or an internationally recognized equivalent, and a minimum of 8 years’ experience in drug safety/pharmacovigilance or as a medical monitor and at least 6 years of clinical experience. Also requires at least 5 years managing medical case review and signal detection. Experience in oncology and/or autoimmune drug development is preferred.
Position also requires: - Strong knowledge of regulatory requirements and guidelines
- Strong communication and interpersonal skills
- Ability to work collaboratively with cross-functional teams
- Strong analytical and problem-solving skills
- Ability to manage multiple projects and priorities
- Strong knowledge and understanding of international safety reporting and pharmacovigilance requirements and signal detection
- Excellent written and oral communication skills
- Ability to travel by car and / or air including overnight 15%
- Strong medical and clinical assessment skills
- Knowledge of drug safety/pharmacovigilance regulations and guidelines, and ability to apply knowledge to evaluation of safety concerns and minimization of patient risk throughout the life cycle of a drug products
- Ability to establish effective working relationships with people in a wide variety of disciplines and backgrounds; manage and prioritize multiple projects and demands simultaneously; rapidly adjust to changing priorities and work effectively under pressure
- Knowledge of relevant FDA, EU and ICH guidelines, initiatives and regulations governing clinical trial safety environments
- Familiarity with Argus safety database
- Knowledge of MedDRA dictionary with relevance to adverse event coding
- Excellent time management and organizational skills
- Ability to demonstrate competencies applicable for job based on Xencor’s Leadership Competency Model
- Ability to eff
ectively manage others through coaching and supervision, in accordance with company policies and practices. Ensures employee performance meets the organization’s expectations for conduct, productivity, quality, continuous improvement, and goal accomplishment.
Physical, Mental and Environment Demands: The physical, mental and working environment demands described are representative of those that must be met by an employee to successfully perform the primary functions of this position.
The physical demands when working in the office environment are normally associated with extended amounts of time sitting and using office equipment, including a computer, keyboard and mouse, which can cause muscle strain. While performing the duties of this job, the employee is frequently required to stand, walk and sit. Periodic light lifting of supplies and materials may apply.
Specific mental demands for the position are listed above under requirements. In addition, mental demands for this position include:
- Ability to multitask without loss of efficiency or accuracy, including the ability to perform multiple duties from multiple sources.
- Ability to work and sustain attention with distractions and/or interruptions.
- Ability to interact appropriately with a variety of individuals including vendors, customers and clients.
- Ability to maintain regular attendance and be punctual.
- Ability to understand, remember and follow verbal and written instructions.
Occasional travel is required to our San Diego, Ca. office. Minimum of once a quarter.
Expected Base Salary Range: $304,000-$345,000
The actual salary will be based on the selected candidate’s qualifications, including skills, competencies, education and experience.Xencor offers a competitive total rewards package including 401k match, healthcare coverage, ESPP and a broad range of other benefits. In
Job Tags
Full time, Work at office, Night shift,